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FDA 510(k)

DIRIA-PROGK IMMUNOASSAY

K-Number: K832694 · 1984-01-11

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1984-01-11
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRIA-PROGK IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1984-01-11 under 510(k) number K832694. The device is classified under product code JLS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRIA-PROGK IMMUNOASSAY?

DIRIA-PROGK IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1984-01-11. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K832694.

When did DIRIA-PROGK IMMUNOASSAY receive FDA 510(k) clearance?

DIRIA-PROGK IMMUNOASSAY received FDA 510(k) clearance on 1984-01-11, under 510(k) number K832694.

Who is the listed applicant for DIRIA-PROGK IMMUNOASSAY?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRIA-PROGK IMMUNOASSAY?

The FDA product code for DIRIA-PROGK IMMUNOASSAY is JLS.

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Related Devices (Code: JLS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbHK973898PROGESTERONE ELISAKmi Diagnostics, Inc.K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.K971725OPUS PROGESTERONEBehring Diagnostics, Inc.K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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